Bone Microarchitecture in Osteopenic Postmenopausal Women

Phase 4

Terminated

• Conditions: Osteoporosis
• Interventions: Drug: placebo; Drug: risedronate

• Registration Number: NCT00577395
• Lead Sponsor: Warner Chilcott

Brief Summary

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Study Start: 2008-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2009-11-18
• Results First Submitted QC: 2009-11-18
• Results First Posted: 2009-12-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Female: 40 and 57 years of age inclusive
• cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
• have osteopenia defines as having the following: have osteopenia defined as having the following:
• Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
• Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
• have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
• hypocalcemia or hypercalcemia of any cause

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	Placebo tablet once a month, orally
2	risedronate	one 150 mg risedronate once a month, orally

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius	12 months	The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).; NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.

Secondary Outcome Measures

Name	Time	Method
Erosion Index of the Distal Radius	6 months	Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Trial Locations

Locations (2)

Research Facility; 🇦🇷 Buenos Aires, Argentina

Research Site; 🇺🇸 Cincinnati, Ohio, United States